Compliance of myBioma
The Regulatory Compliance Journey of myBioma Biome Diagnostics GmbH is an Austrian medtech start-up utilizing the genetic information of the microbiome and AI to develop medical diagnostic software for doctors. Biome Dx products utilize technologies such as next-generation sequencing, pipeline architectures and microservices. With their lifestyle product myBioma every European has the possibility to learn […]
How to Add Page Numbers to the PDF Exports of Quality Records in Confluence
Paper-based Quality Management Systems are now (almost) a thing of the past (it’s sooo 20th century…). But in some cases, printing records and documents from the eDMS is necessary, or at least exporting them to PDF. The requirements for paper documents are the same as digital documents. But, unlike electronic formats, physical misplacement or loss […]
Medical Device Compliance & Atlassian Cloud
On the 16th of October 2020, Atlassian announced radical changes to their offering. From February 2nd 2021, Atlassian will not sell any new Server licenses for any of their products. A year later, in February 2022, it will not be possible to upgrade or downgrade your Atlassian Server product tier. From February 2023, it will […]
How We Managed the Compliance of Personal Protective Equipment
The Regulatory Compliance Journey of XRGO Nathaniel Victor, CEO of XRGO: “We got involved in PPE manufacturing as a goodwill donation/gesture of time, energy, products and financial support to the hospitals and local municipalities. Early on, our suppliers in China informed us that COVID-19 was serious and they advised that we protect our staff and […]
How to Use Confluence Pages as Templates
Summary SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows the user to use any Confluence page as a template, copying it automatically into the existing space at a click of a button. Features include the addition of prefixes, suffixes, timestamp and more. This bypasses the use of Confluence […]
How Cibiltech became FDA 21 CFR 11 Compliant on Atlassian Confluence
Customer Story on the MediCompli Solution at Cibiltech NOTE: Cibiltech has now successfully migrated from Atlassian Server to Atlassian Cloud and have implemented the Cloud eQMS Solution as their Quality Management Solution. Cibiltech Cibiltech is a French medical device company developing an AI based personalized medicine solution for better patient care. Their most recent solution […]
How SoftComply eQMS helped speed up the CE-marking of munevo DRIVE – a Case Study
“If you are developing medical device software and need to go through the certification process, look what SoftComply has to offer!”, says Claudiu, the co-founder and CEO of Munevo. Munevo is the company behind munevo DRIVE – the first wheelchair control system that uses smart glasses enabling people to become more independent and safely drive […]
How to Secure your Documents in Confluence?
This short post will provide you insight into taking control over your document management in Confluence Server. This post is not going to touch regular security policies like VPN, firewalls, security policies and ohter things that are outside of the Confluence Server. In other words, all the really technical things are left out and we […]
What is Software Tool Validation?
Modern medical device regulations are putting more and more emphasis on the management of software tools. These tools are software packages that are not part of the medical devices themselves, but support the device during its lifecycle. Nowadays companies use dozens of applications, ranging from accounting tools to email clients to software compilers. Of course […]
The Importance of IEC 62304 Compliance Part 2
Following up on our first blog post on how to become a trusted software supplier to established medical device manufacturers with the help of IEC 62304, we will now shed some light on specific clauses and requirements of that standard. IEC 62304:2006/Amd 1:2015, 4.3 – Software Safety Classification The 2015 amendment provides more clarity on […]
